Isotretinoin: uses, dosing, side effects & brands
Isotretinoin is a retinoid sold in the U.S. under 4 brand and generic names, for acne vulgaris, leukemia and neuroblastoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Retinoid
- Treats
- Acne Vulgaris, Leukemia and Neuroblastoma
- Available as
- Capsule
- Sold as
- 4 products — Absorica, Absorica Ld and Accutane, and others
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $155 for a 30-count supply — not your price
- Boxed warning
- Boxed warning
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How isotretinoin is dosed
From the FDA label for Absorica (application NDA021951). Other isotretinoin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Evaluations Prior To Prescribing and Use of ABSORICA/ABSORICA LD: In patients who can get pregnant, only prescribe ABSORICA/ABSORICA LD after verification and documentation that they are not pregnant. See the Full Prescribing Information for the detailed requirements prior to prescribing ABSORICA/ABSORICA LD ( 2.1 , 8.3 ) Complete the following laboratory tests in all patients: fasting lipid profile and liver function tests. ( 2.1 ) ABSORICA is not substitutable with ABSORICA LD because of different bioavailability and recommended dosage. ( 2.2 , 5.3 ) Recommended dosage for (2.2 ): o ABSORICA is 0.5 to 1 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks ( 2.1 ) o ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks ( 2.1 ) Adult patients with very severe disease (scarring, trunk involvement) may increase dosage to 2 mg/kg/day of ABSORICA (1.6 mg/kg/day of ABSORICA LD) in divided doses. ( 2.1 ) Once daily dosing is not recommended. ( 2.1 ) If a dose of ABSORICA/ABSORICA LD is missed, just skip that dose. Do not take two doses of ABSORICA/ABSORICA LD at the same time. ( 2.1 ) 2.1 Evaluations Prior To Prescribing and Use of ABSORICA/ABSORICA LD In patients who can get pregnant, only prescribe ABSORICA/ABSORICA LD after verification and documentation that they are not pregnant [see…
Isotretinoin side effects
The following adverse reactions with ABSORICA/ABSORICA LD or other isotretinoin capsule products are described in more detail in other sections of the labeling: Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.1 )] Psychiatric Disorders [see Warnings and Precautions ( 5.4 )] Intracranial Hypertension (Pseudotumor Cerebri) [see Warnings and Precautions ( 5.5 )] Serious Skin Reactions [see Warnings and Precautions ( 5.6 )] Pancreatitis [see Warnings and Precautions ( 5.7 )] Lipid Abnormalities [see Warnings and Precautions ( 5.8 )] Hearing Impairment [see Warnings and Precautions ( 5.9 )] Hepatotoxicity [see Warnings and Precautions ( 5.10 )] Inflammatory Bowel Disease [see Warnings and Precautions ( 5.11 )] Musculoskeletal Abnormalities [see Warnings and Precautions ( 5.12 )] Ocular Abnormalities [see Warnings and Precautions ( 5.13 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.14 )] The following adverse reactions associated with the use of isotretinoin capsules were identified in clinical trials or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dose Relationship Cheilitis and hypertriglyceridemia were dose related. Body as a Whole Fatigue, irritability, pain, allergic…
Who shouldn’t take isotretinoin
ABSORICA/ABSORICA LD is contraindicated in: Pregnancy [see Warnings and Precautions ( 5.1 ) and Use in Specific Populations ( 8.1 )] . Patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred) [see Warnings and Precautions ( 5.14 )] . ABSORICA/ABSORICA LD is contraindicated in: Pregnancy ( 8.1 ) Patients with hypersensitivity to isotretinoin (or Vitamin A) or any of its components ( 5.14 )
Isotretinoin drug interactions
Vitamin A: avoid concomitant use (7.1) Tetracyclines: avoid concomitant use (7.2) 7.1 Vitamin A Avoid concomitant use of ABSORICA/ABSORICA LD with supplements containing vitamin A. ABSORICA/ABSORICA LD is closely related to vitamin A. Therefore, concomitant use of ABSORICA/ABSORICA LD with vitamin A may lead to ABSORICA/ABSORICA LD-associated adverse reactions. 7.2 Tetracyclines Avoid concomitant use of ABSORICA/ABSORICA LD with tetracyclines because isotretinoin use has been associated with a number of cases of intracranial hypertension ( pseudotumor cerebri) , some of which involved concomitant use of tetracyclines [see Warnings and Precautions (5.5) ] . 7.3 Oral Contraceptives Isotretinoin Capsules did not result in clinically significant changes in the pharmacokinetics of norethindrone and ethinyl estradiol when used concomitantly with a norethindrone and ethinyl estradiol oral contraceptive [see Clinical Pharmacology ( 12.3 )]. It is not known if there is an interaction with the concomitant use of ABSORICA/ABSORICA LD with other oral contraceptives.
Every isotretinoin product we track (4)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Capsule | Generic | $155 | View → | |
| 2 | Not yet rated | Prescription | Capsule | Generic | $155 | View → | |
| 3 | Not yet rated | Prescription | Capsule | Generic | $155 | View → | |
| 4 | Not yet rated | Prescription | Capsule | Generic | $155 | View → |
What isotretinoin pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Isotretinoin recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Claravis (isotretinoin capsule
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Teva Pharmaceuticals USA, Inc · Apr 6, 2026
Amnesteem (Isotretinoin) Capsules
Failed Dissolution Specifications
MYLAN PHARMACEUTICALS INC · Feb 24, 2026
Isotretinoin Capsules
Superpotent and Subpotent
Teva Pharmaceuticals USA, Inc · Jan 12, 2026
Isotretinoin Capsules
Superpotent and Subpotent
Teva Pharmaceuticals USA, Inc · Jan 12, 2026
Isotretinoin Capsules
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Teva Pharmaceuticals USA, Inc · Mar 28, 2024
Can you crush or split isotretinoin?
At least one isotretinoinproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each isotretinoin label says about crushing, splitting and chewingHow long isotretinoin keeps
No isotretinoin label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does isotretinoin expire? The in-use limits and storage rules from its labelsIsotretinoin and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for isotretinoin: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the use of isotretinoin during breastfeeding. Various topical agents that are less likely to be absorbed by the mother may be preferred during breastfeeding, especially while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised October 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about isotretinoin
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 16,069 reports naming isotretinoin, and the FDA flagged 55% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- pregnancy1,068 reports
- depression1,051 reports
- exposure during pregnancy744 reports
- abortion induced696 reports
- adverse drug reaction633 reports
- dry skin577 reports
- headache569 reports
- arthralgia560 reports
Read these as a signal, not a rate. A report does not mean isotretinoin caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related guides
Related calculators
Frequently asked questions
What is isotretinoin?
ABSORICA ABSORICA (isotretinoin) Capsules contain 10 mg, 20 mg, 25 mg, 30 mg, 35 mg or 40 mg of isotretinoin (a retinoid) in hard gelatin capsules for oral administration. In addition to the active ingredient, isotretinoin, each capsule contains the following inactive ingredients: propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. The gelatin capsules contain the following dye systems: •10 mg – iron oxide (yellow) and titanium dioxide; •20 mg – iron oxide (red), and titanium dioxide; •25 mg – FD&C Blue #1, FD&C Yellow #5 [see Warnings and Precautions (5.14) ] , FD&C Yellow #6 and titanium dioxide; •30 mg – iron oxide (black, red and yellow) and titanium dioxide; •35 mg – FD&C Blue #2, iron oxide (black, red and yellow) and titanium dioxide; •40 mg – iron oxide (black, red and yellow) and titanium dioxide. ABSORICA LD ABSORICA LD (isotretinoin) Capsules contain 8 mg, 16 mg, 20 mg, 24 mg, 28 mg and 32 mg of micronized isotretinoin (a retinoid) in suspension filled in hard gelatin capsules for oral administration.
What kind of drug is isotretinoin?
The FDA classifies isotretinoin as a retinoid. Retinoids are vitamin A derivatives that enter skin cells and switch on retinoic acid receptors in the nucleus, which changes how genes are read. This normalizes how skin cells grow and shed, unclogs pores, calms inflammation, and over time boosts collagen production. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take isotretinoin with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run isotretinoin against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is isotretinoin sold under?
We track 4 isotretinoin-containing products in the U.S.: Absorica, Absorica Ld, Accutane and Sotret. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does isotretinoin come in?
Across the brands we track, isotretinoin is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic isotretinoin?
Yes. Our catalog lists 1 generic isotretinoin product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has isotretinoin been recalled?
The FDA's Enforcement database lists at least 5 recall records whose product description mentions isotretinoin. The most recent: Claravis (isotretinoin capsule (Apr 6, 2026). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Isotretinoin: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/isotretinoin
- MLA
- “Isotretinoin: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/isotretinoin.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for isotretinoin on DailyMed (NIH) ↗ — including its boxed warning in full.